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Shenzhen Zijian Biotechnology Co., Ltd

China·CN-MF-000022829

Last updated September 18, 2026

About

Address:5th/7th floor, Building A1, Qiaode Science and Technology Park, Guangming District, Shenzhen, China

From the manufacturer's own website, in their original language. Source

What Shenzhen Zijian Biotechnology Co., Ltd makes

Shenzhen Zijian Biotechnology Co., Ltd manufactures diagnostic test kits for laboratory use, including fluorescence immunoassay and chemiluminescent immunoassay (CLIA) devices. Their products detect biomarkers such as creatine kinase isoenzyme (CK-MB), SARS-CoV-2 neutralizing antibodies, D-dimer, Helicobacter pylori antibodies, and cancer-related markers like CA15-3. They also supply specimen collection tools, including disposable virus sampling tubes and flocked swabs for clinical sampling.

The company’s diagnostic devices fall under Class A and Class I classifications, with some listed as In Vitro Diagnostic (IVD) General category devices. Their products are registered in the EU’s eudamed database, ensuring traceability and compliance with regulatory requirements. The manufacturer operates from China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
China
Address
502, Building A, Qiaode Science Park, No.7, Guangming Hi-tech Park West, Tianliao Community, Yutang Street, Shenzhen, China
Phone
+86-755-26614284
PRRC Contact
Jinshan Guo
EUDAMED SRN
CN-MF-000022829
FDA FEI Number
—
DUNS Number
—

Catalogue (253)

Page 2 of 6
DeviceModel / ReferenceRegistriesClassStatus
Cortisol Detection Kit(CLIA) 18-02-0183
EUDAMED
IVD GeneralActive
Intact Parathyroid Hormone (Intact PTH) Detection Kit(CLIA) 18-02-0190
EUDAMED
IVD GeneralActive
H. Pylori Ag FIA Kit 18-02-0067
EUDAMED
IVD GeneralActive
MP IgM FIA Kit 18-02-0070
EUDAMED
IVD GeneralActive
Rotavirus (group A/B/C) Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0022
EUDAMED
IVD GeneralActive
Dengue IgG/IgM FIA Kit 18-02-0072
EUDAMED
IVD GeneralActive
Lipoprotein-associated phospholipaseA2(Lp-PLA2) Detection Kit(CLIA) 18-02-0141
EUDAMED
IVD GeneralActive
Aldosterone(ALD) Detection Kit(CLIA) 18-02-0182
EUDAMED
IVD GeneralActive
Reverse Triiodothyronine Detection Kit(CLIA) 18-02-0168
EUDAMED
IVD GeneralActive
IgE FIA Kit 18-02-0050
EUDAMED
IVD GeneralActive
SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit(Fluorescence Immunoassay) 18-02-0100
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0219
EUDAMED
IVD GeneralActive
Follicle Stimulating Hormone (FSH) Detection Kit(Fluorescence Immunoassay) 18-02-0104
EUDAMED
IVD GeneralActive
Double fluorescence staining solution 18-05-0027
EUDAMED
Class AActive
Rhinovirus, Respiratory Syncytial Virus & respiratory Adenovirus Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0013
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0184
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0182
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0039
EUDAMED
Class IActive
Anti-TPO FIA Kit 18-02-0048
EUDAMED
IVD GeneralActive
MP IgG FIA Kit MP IgG FIA Kit
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold) 18-02-0135
EUDAMED
IVD GeneralActive
Gentrin 17 Detection Kit(CLIA) 18-02-0172
EUDAMED
IVD GeneralActive
C-Reactive Protein (CRP) Detection Kit(CLIA) 18-02-0146
EUDAMED
IVD GeneralActive
Cardiac Troponin I (cTnI) Detection Kit(Fluorescence Immunoassay) 18-02-0117
EUDAMED
IVD GeneralActive
Triiodothyronine (T3) Detection Kit(Fluorescence Immunoassay) 18-02-0105
EUDAMED
IVD GeneralActive
Mycoplasma Pheumonia IgM (MP IgM) Detection Kit(CLIA) 18-02-0194
EUDAMED
IVD GeneralActive
Estradiol ( E2 ) Detection Kit(CLIA) 18-02-0153
EUDAMED
IVD GeneralActive
S100-β Protein(S100-β)Detection Kit(CLIA) 18-02-0143
EUDAMED
IVD GeneralActive
Fibrin/Fibrinogen Degradation Products(FDP) Detection Kit(CLIA) 18-02-0201
EUDAMED
IVD GeneralActive
Adenovirus IgM Detection Kit(CLIA) 18-02-0192
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0214
EUDAMED
IVD GeneralActive
Enterovirus type 71 (EV71) Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0019
EUDAMED
IVD GeneralActive
Triiodothyronine(T3) Detection Kit(CLIA) 18-02-0165
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold) 18-02-0040
EUDAMED
IVD GeneralActive
Progesterone(P)Detection Kit(CLIA) 18-02-0154
EUDAMED
IVD GeneralActive
Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 18-02-0024
EUDAMED
IVD GeneralActive
Estradiol (E2) Detection Kit (Fluorescence Immunoassay) 18-02-0124
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0213
EUDAMED
IVD GeneralActive
Human sex hormone-binding globulin Detection Kit(CLIA) Human sex hormone-binding globulin Detection Kit(CLIA)
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0154
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0172
EUDAMED
IVD GeneralActive
Thyroglobulin (Tg) Detection Kit(CLIA) 18-02-0169
EUDAMED
IVD GeneralActive
Prolactin (PRL) Detection Kit(Fluorescence Immunoassay) 18-02-0112
EUDAMED
IVD GeneralActive
Thrombin-Antithrombin Complex(TAT) Detection Kit(CLIA) 18-02-0197
EUDAMED
IVD GeneralActive
Folic Acid (FA) Detection Kit(CLIA) 18-02-0186
EUDAMED
IVD GeneralActive
Influenza A (H1N1) Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0011
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0175
EUDAMED
IVD GeneralActive
Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 18-02-0029
EUDAMED
IVD GeneralActive
Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification) 18-02-0128
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0089
EUDAMED
Class IActive

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